Core Insights - BD (Becton, Dickinson and Company) has received WHO prequalification for its Onclarity™ HPV Assay, enhancing access to cervical cancer screening in low- and middle-income countries [1][4]. Product Details - The BD Onclarity™ HPV Assay detects 14 high-risk HPV types, allowing for individual identification of six high-risk types and three genotype groups, which aids in risk stratification and patient management [2][3]. - The assay is approved for self-collection, including at-home self-collection in countries recognizing the CE mark, thus improving access in resource-limited settings [2][4]. Impact on Healthcare - The ability to identify more individual HPV types enables clinicians to manage high-risk cases more effectively and guide follow-up for low-risk patients, ensuring appropriate care and reducing resource demand [3][4]. - WHO emphasizes the importance of regular screening to prevent cervical cancer, which is the fourth most common cancer in women globally, with a woman dying from it every 90 seconds [7]. System Features - The BD Viper™ LT System is designed for decentralized testing, featuring a compact design that automates sample preparation and amplification, making it suitable for labs with limited infrastructure [5]. - The BD COR™ System offers high-throughput automation for centralized labs, capable of processing nearly 1,650 tests and delivering up to 1,000 results in 24 hours, maximizing efficiency [6].

Core Insights - BD has submitted an application to the U.S. FDA for a new at-home HPV test that allows self-collection of samples, utilizing a Q-tip-sized swab that simplifies lab processing and reports more high-risk HPV strains than any other test available [1][2]. Group 1: Product Features and Benefits - The new HPV test includes a self-collection swab technology that is safe, simple, and non-invasive, eliminating the need for liquids or complex devices, and facilitating convenient mailing from home to the lab [3]. - The BD Onclarity™ Assay can report more individual high-risk strains of HPV than any other test, addressing the changing prevalence of high-risk genotypes beyond HPV 16/18 [5]. - The self-collected swab requires no manual sample preparation, allowing laboratory technologists to focus on higher-value work, and ensures specimen integrity from collection to result reporting [4]. Group 2: Market Demand and Trends - A survey by Harris Poll indicated that 72% of U.S. women have delayed gynecology visits, with 81% preferring more comfortable and less invasive testing options, and 74% showing interest in self-collection tests at home [6]. - The American Society for Colposcopy and Cervical Pathology has included the BD Onclarity™ Assay in its guidelines due to its ability to identify more high-risk HPV types, and self-collection is also recommended in draft guidelines by the U.S. Preventive Services Task Force [7]. Group 3: Company Overview - BD is one of the largest global medical technology companies, focused on improving medical discovery, diagnostics, and care delivery, with a commitment to enhancing safety and efficiency in healthcare [8].